Few specific intra-operative surgical tools or devices have been developed for determining the proper size for breast implants which may be, for example, used in the setting of immediate breast reconstruction. Some of these methods and surgical tools have been developed for office based assessments both for reconstructive and cosmetic enhancement purposes. Additional methods and surgical tools and devices have been developed for intra-operative use in reconstructive patients specifically.
By way of example, one embodiment of a breast reconstructive procedure employs a tissue expander to create a pocket underneath the skin (subcutaneous) and chest muscle (sub-pectoral) of a patient. The tissue expander may be expanded over a period of several weeks to months to create a pocket or space having a size sufficient to accept an implant. Thereafter, in a second surgical procedure, a breast implant may be inserted into the pocket created by the tissue expander, and in place thereof.
More recently, a “one-step” or “direct-to-implant” (“DTI”) breast reconstructive procedure has been developed. DTI procedures may be desirable in that they may involve a single procedure wherein the mastectomy and reconstruction are both performed and completed under one anesthetic. In this regard, the insertion of an acellular dermal matrix (“ADM”) material may be employed to assist in forming a pocket and support for the implant, thus providing a first layer of soft tissue coverage over the implant, the second more superficial layer being the skin and subcutaneous tissue which constitutes the mastectomy skin flaps.
However, DTI breast reconstruction is dependent on sufficient skin laxity to allow for safe wound closure without undue tension that could compromise healing and jeopardize the reconstruction. Therefore, in the setting of DTI breast reconstruction, whether unilateral or bilateral, the two critical steps are the proper sizing and positioning of the breast implant(s), and the proper determination of the suture line for insetting of the ADM. Accordingly, improved apparatuses, tools, devices, systems, and methods for determination of optimal breast implant size and proper suture line insetting of the ADM may be desirable.